Cleared Traditional

K965207 - RID-DECUBE II

K965207 is an FDA 510(k) clearance for RID-DECUBE II, manufactured by Skin Care Management, Inc.. The device is a Class 2 General Hospital device with product code FNM cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K965207 · Skin Care Management, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
237d
Days
Class 2
Risk

K965207 is an FDA 510(k) clearance for the RID-DECUBE II. Classified as Mattress, Air Flotation, Alternating Pressure (product code FNM), Class II - Special Controls.

Submitted by Skin Care Management, Inc. (East Burnswick, US). The FDA issued a Cleared decision on August 21, 1997 after a review of 237 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5550 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Skin Care Management, Inc. devices

FDA 510(k) Submission Details - K965207

510(k) Number K965207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1996
Decision Date August 21, 1997
Days to Decision 237 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 129d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FNM Device Classification - Class 2, Special Controls

Product Code FNM Mattress, Air Flotation, Alternating Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FNM Mattress, Air Flotation, Alternating Pressure

All 40
Devices cleared under the same product code (FNM) and FDA review panel - the closest regulatory comparables to K965207.
SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
K970081 · Cathay Consolidated, Inc. · Nov 1997
BARIAIR
K955243 · Kinetic Concepts, Inc. · Oct 1997
KT AIR BED
K970468 · Kinetic Concepts, Inc. · Sep 1997
ALTERNATING PRESSURE AIR FLOTATION MATTRESS
K972153 · Decubiti Concepts, Inc. · Jul 1997
MODIFIED PEDIKAIR
K954320 · Kinetic Concepts, Inc. · Jul 1997
REST MATTRESS
K971568 · Rest Mattress · Jul 1997